Recruiting

Olfaction Impact

Sponsor:

Unity Health Toronto

Code:

NCT03773705

Conditions

Pituitary Tumor

Surgery

Olfactory Nerve Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Electrocautery versus scalpel

Study Details

Brief summary:

Pituitary tumours have an estimated prevalence of 20% in the general population and the number of clinically relevant pituitary adenomas is increasing with time. When symptomatic, the standard of care required for pituitary adenomas is resection through an endoscopic transsphenoidal approach. There is however significant olfactory dysfunction following endoscopic transsphenoidal pituitary surgery with approximately 23% of patients reporting some degree of worsening in their sense of smell in the postoperative period.

Pedicled nasoseptal flaps are used to repair skull base defects following resection of skull base tumours. The superior incision is placed in close proximity to olfactory mucosa. Currently, these flaps are raised either with the use of electrocautery or scalpel. The use of electrocautery in surgery has provided surgeons with greater hemostasis when compared to a scalpel. This is of utmost importance in many regions of the head \& neck where highly vascularized tissue results in difficulties achieving adequate hemostasis and therefore limiting view of the surgical field. However, the use of electrocautery increases thermal damage to surrounding tissue and impairs wound healing when compared to a scalpel.

Although the transmission of thermal energy via electrocautery to adjacent mucosa containing olfactory epithelium may theoretically contribute to olfactory disturbances, no prospective randomized controlled trials have yet examined the impact of these two different techniques on postoperative olfactory function. The purpose of this research study is to determine the effects, if any, of electrocautery versus scalpel on olfaction in raising the nasoseptal flap for repairing skull base defects following transphenoidal surgery.

Conditions

Pituitary Tumor

Surgery

Olfactory Nerve Injuries

Study ID

NCT03773705

Start date

Feb 25, 2019

Status verified date

Mar, 2019

Completion date

Dec 31, 2019

Anticipated

Primary completion date

Oct 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patients (age ≥18 years)
  • Patients with tumours of the pituitary gland electively scheduled for endoscopic transsphenoidal surgery with nasoseptal flap coverage

Exclusion Criteria:

  • Documented evidence of sinonasal disease on either nasal endoscopy or radiography
  • Patients with a clinical history of asthma and/or sinonasal disease
  • Previous sinus surgery
  • Previous skull base surgery
  • History of pre-existing hyposmia or anosmia
  • Use of medication(s) known to alter sense of smell at time of test
  • UPSIT scores <5 indicating a functional component to alteration in olfaction
  • Development of postoperative cerebrospinal fluid leak necessitating re-entry into the operative field containing the nasoseptal flap

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Electrocautery group

Electrocautery used to raise pediclued nasoseptal flaps to repair skull based defects following endoscopic transphenoidal surgery.

active comparator: Scalpel group

Scalpel used to raise pediclued nasoseptal flaps to repair skull based defects following endoscopic transphenoidal surgery.

Interventions

Electrocautery versus scalpel

Electrocautery versus scalpel in the elevation of nasoseptal flaps following endoscopic transsphenoidal pituitary surgery

Primary outcome measure

  • Change in University of Pennsylvania Smell Identification Test (UPSIT) [ Time Frame: Initial visit and at 1, 3 and 6-month follow-up visits ]
  • Change in Sniffin' Sticks [ Time Frame: Initial visit and at 1, 3 and 6-month follow-up visits ]
  • Change in Sino-Nasal Outcome Test-22 (SNOT-22) [ Time Frame: Initial visit and at 1, 3 and 6-month follow-up visits ]
  • Change in Skull Base Inventory (SBI) [ Time Frame: Initial visit and at 1, 3 and 6-month follow-up visits ]
  • Change in Pre-Op and Post-Op Endoscopy Scores [ Time Frame: Initial visit and at 1, 3 and 6-month follow-up visits ]

Central Contacts and Locations

Central contacts

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

More Information

Sponsor

Unity Health Toronto

Last update posted

Mar 15, 2019

Last verified

Mar, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2019-03-15.